**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. **The PPD FSP Solution:** PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success. Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience. **Discover Impactful Work:** **As a Project Specialist you will be a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness.** **A day in the Life:** + Works in close partnership with the Study Manager or Study Delivery Lead on end-to-end operational study delivery activities, from study set up to study archival, with the focus on setting up, maintaining and ensuring completeness of internal systems/databases/tracking tools and project plans (CSAP). + Works cross-functionally, with internal and external partners, on clinical study management activities, as agreed with the Study Delivery Lead and to current clinical study regulations. + Responsible for monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives. + Responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans. + Responsible for vendor management and Facilitating and maintaining interactions and meetings with internal and external partners. Acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals and import license status. + Coordinating study-related activities and managing study team's communication – meetings (preparation, scheduling, meeting minutes), info-spaces, newsletters, action logs, communication plans, team lists. + Overseeing delivery of clinical supplies, investigational products and all study materials provided by the Sponsor or external service providers and communicating issues/risks to continuity of supplies and proposing solutions as appropriate. + Responsible for data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality. + Budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the SDL. **Education** + Bachelor's degree in life sciences or other related field + Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) **Knowledge, Skills, Abilities** + Effective oral and written communication skills; + Foundational knowledge of clinical study delivery process, including regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience in using Trial Master File industry accepted standard. + Excellent social skills; + Strong attention to detail and quality of documentation; + Good negotiation skills; + Good computer skills and the ability to learn appropriate software; + Good English language and grammar skills; + Previous Global Study management experience + Previous vendor management experience + Ability to manage multiple competing priorities within various clinical studies with good planning, time management and prioritization skills. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. **Apply today! http://jobs.thermofisher.com** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. **Accessibility/Disability Access** Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.